XprESS LoProfile MSB&LLFRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00857326005017), received between Apr 12, 2018 and Dec 16, 2025 — classified as 5 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON PROVIDED ADDITIONAL INFORMATION THAT NO ANATOMICAL ABNORMALITIES NOTED IN THE PATIENT CT SCAN PRIOR TO PROCEDURE. NO MEDICATIONS WERE PROVIDED. THE PATIENT IS NOTED TO BE DOING WELL IN POST PROCEDURE CONSULTATION.

  Patient problems: Asystole; Bradycardia

  MAUDE report 23818406 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SINUS CASE WITH THE XPRESS DEVICE THE SURGEON SUCCESSFULLY BALLOONED BOTH FRONTAL AND MAXILLARY SINUSES. THE SURGEON THEN BALLOONED THE SPHENOID SINUS AND UPON PULLING THE BALLOON OUT OF THE SINUS, THE PATIENT HAD AN UNUSUAL AMOUNT OF BLEEDING. THE PATIENT WAS TREATED WITH A NASAL PACKING AND EMBOLIZATION.

  Patient problems: Epistaxis

  MAUDE report 16645740 ↗
• InjurySep 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A CSF LEAK IMMEDIATELY FOLLOWING A MULTI-SINUS BALLOON DILATION PROCEDURE. THE PATIENT HAD SURGERY TO PATCH THE CSF LEAK, WAS HOSPITALIZED FOR 2-3 DAYS AND THEN DISCHARGED. NO FURTHER PATIENT INJURY OR COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 10541645 ↗
• InjurySep 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT FRONTAL BALLOON DILATION WITH AN XPRESS BALLOON DEVICE AND FOLLOWED BY A FULL FESS OF THE FRONTAL, SPHENOID, MAXILLARY AND ETHMOID SINUSES WITH SEPTOPLASTY AND BILATERAL TURBINATE REDUCTION A CSF LEAK WAS NOTICED NEAR THE LEFT FRONTAL SINUS. THE CSF LEAK WAS REPAIRED WITH A PATCH USING SKIN GRAFT ALONG WITH PACKING PRODUCT. THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION AND DISCHARGED HOME THE FOLLOWING MORNING WITHOUT FURTHER ISSUES. NO FURTHER PATIENT INJURY OR COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 7850762 ↗
• InjuryApr 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED SUBCUTANEOUS EMPHYSEMA OF THE LOWER FACE. AFTER THE PHYSICIAN SUCCESSFULLY COMPLETED A LEFT SIDE EUSTACHIAN TUBE DILATION, THE PATIENT WAS DISCHARGED HOME. TWO (2) DAYS LATER THE PATIENT EXPERIENCED LEFT SIDED FACIAL SWELLING/INFLAMMATION AND WAS EXAMINED BY HER PHYSICIAN. THE PATIENT HAD A CAT SCAN AND WAS FOUND TO HAVE SUBCUTANEOUS EMPHYSEMA OF THE LOWER FACE. THE PATIENT WAS GIVEN A PRESCRIPTION OF CIPRO AND PREDNISONE AND WAS SENT HOME. THE PATIENT IS DOING WELL WITH NO FURTHER COMPLICATIONS.

  Patient problems: Inflammation; No Code Available

  MAUDE report 7426517 ↗